Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-28 @ 7:51 PM
Study NCT ID:
NCT01529567
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2012-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 311}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-14', 'studyFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2012-02-08', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal symptom rating scale', 'timeFrame': '1 week before randomization'}, {'measure': 'Gastrointestinal symptom rating scale', 'timeFrame': '10 weeks after randomization (i.e. after conclusion of treatment)'}, {'measure': 'Gastrointestinal symptom rating scale', 'timeFrame': '36 weeks after randomization (i.e. 6 months after conclusion of treatment)'}], 'secondaryOutcomes': [{'measure': 'Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)', 'timeFrame': '1 week before randomization'}, {'measure': 'Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)', 'timeFrame': '10 weeks after randomization (i.e. after conclusion of treatment)'}, {'measure': 'Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)', 'timeFrame': '36 weeks after randomization (i.e. 6 months after conclusion of treatment)'}, {'measure': 'Visceral Sensitivity Index (VSI)', 'timeFrame': '1 week before randomization'}, {'measure': 'Visceral Sensitivity Index (VSI)', 'timeFrame': '10 weeks after randomization (i.e. after conclusion of treatment)'}, {'measure': 'Visceral Sensitivity Index (VSI)', 'timeFrame': '36 weeks after randomization (i.e. 6 months after conclusion of treatment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '34256715', 'type': 'DERIVED', 'citation': 'Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6.'}]}, 'descriptionModule': {'briefSummary': 'Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluency in Swedish\n* IBS-diagnosis established by physician\n* Fulfillment of Rome III criteria for IBS\n\nExclusion Criteria:\n\n* Diarrhea predominance with no colonoscopy performed\n* Blood in stool without benign medical explanation\n* Rapid weight loss without benign medical explanation\n* Ongoing alcohol or drug abuse\n* Suicidal ideation'}, 'identificationModule': {'nctId': 'NCT01529567', 'briefTitle': 'Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'orgStudyIdInfo': {'id': 'IBS-0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CBT without exposure', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy without exposure']}, {'type': 'EXPERIMENTAL', 'label': 'CBT with exposure', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy with exposure']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy without exposure', 'type': 'BEHAVIORAL', 'description': '10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility.', 'armGroupLabels': ['CBT without exposure']}, {'name': 'Cognitive Behavioral Therapy with exposure', 'type': 'BEHAVIORAL', 'description': '10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations.', 'armGroupLabels': ['CBT with exposure']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Brjánn Ljótsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brjann Ljotsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}